FDA 510(k)

Sistema RXi ACIST (016616); Catéter Navvus II ACIST (016675_)

N.º K: K233904 · 2024-07-17

Fecha de decisión2024-07-17

Código de productoDXO

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K233904. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K233904.

When did ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ receive FDA 510(k) clearance?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ received FDA 510(k) clearance on 2024-07-17, under 510(k) number K233904.

Who is the listed applicant for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

The FDA 510(k) record lists Acist Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

The FDA product code for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is DXO.

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Otros registros que enlistan a Acist Medical Systems, Inc. como solicitante

K262115VueJect® Ultrasound Enhancing Agent Delivery System K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)K252653Sistema de Diagnóstico ACIST Pro (019304); Unidad de Procesamiento Montada en Cama; Módulo AngioTouch; Carro ACIST Pro; Cable de Transductor Único; Cable de Transductor Triple K203004Sistema de Entrega de Contraste ACIST CVi1, Sistema de Entrega de Contraste ACIST CVi K193183Sistema ACIST HDi, Catéter de Ultrasonido Intravascular ACIST Kodama K190473Sistema RXi ACIST y Catéter Navvus II

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Fuente oficial

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